Manager- EU Compliance

Sun Pharma

Paonta Sahib, IN Onsite Paonta Sahib - Quality Control

About this role

Job Title:	EU Compliance Specialist		Business Unit:	Global Quality and Compliance
Job Grade	Manager-1		Location :	Paonta Sahib/


At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: The EU Compliance Specialist will be responsible for supporting EU-related activities in the Sun India DF site which manufacture products for the EU and UK markets. Documents related to EU-products such as (but not limited to) Change Controls (including Temporary CC’s), Market Complaints, Investigations associated with Deviations, OOS/OOT shall be screened for robustness prior to sharing with the EU QP teams. Supporting site compliance to EU-GMP Guidelines and their implementation, in addition to supporting ad-hoc requests from the EU Compliance Lead and/or EU QP and Compliance teams will be required. Major Tasks & Responsibilities: Assess all site investigation related to EU-products for completeness and robustness Liaise with the EU Compliance Lead on all matters of concern related to EU GMP’s and EU-products. Triage investigations at site related to EU products and confirm accuracy of classification by site. Ensure all Change Controls with major or critical impact (impact to either product process validation status or marketing Authorisation) are shared for pre-approval by the EU QP’s. Maintain open and effective communication channels between India Sites (EU supplying) and EU Compliance Lead so that information flowing to EU QP’s is accurate. Ensure regular communication cadence with the EU-Compliance Lead Support quality operations when required and aligned with EU-Compliance Lead and/or EU QP’s and Head of Compliance WEU. Ensure timely communications with both India and EU stakeholders according to the requirements of Quality Agreements. Support the maintenance and update of the local site Quality Management System as aligned with EU-Compliance Lead
Travel Estimate
Job Requirements
Educational Qualification		Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education
Experience		Tenure: Tenure: Minimum 10 years Industry: (Bio) pharmaceutical, sterile manufacturing (as required per site) Content areas: Manufacturing, QA /QC. QA manufacturing operation Technical skills/job specific competencies Experience on review of batch documentation and preparation for batch certification. Good experience and knowledge of QA/QC and EU regulatory compliance Good knowledge and experience in DF pharmaceutical processes and QA/QC operations. Good understanding of change control processes and interaction with regulatory affair processes. Capable of reviewing and assessing manufacturing and analytical technical documents and provide sound quality assessments on change controls, deviations and complaints. Experience working with electronic Document Management, electronic Training systems and e.g. Trackwise